21st National Conference on Pharmaceutical and Chemical

Diversion

Pill Mills & Pain Clinics United States v. Volkman

I. Special Agent Jerrel Smith (1963- 2010)

II. Overview of Pill Problem

III. The Story of Paul Volkman

IV. Investigation

V. Charges

VI. Trial

VII. Sentencing

2

Overview

“When you win don’t say anything … when you lose say even less”

Paul Brown Football Legend

3

What this is Not!

“If you prove the cause, you at once prove the effect; and conversely nothing can exist without its cause

-Aristotle-

4

Cause and Effect

Death in RuralAmerica

aStudy in Cause and Effect

5

6

I. Overview of Pill Problem

Source: CDC

7

A Nationwide Problem

Source: OH Department of Health

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An Ohio Problem

Source: OH Assoc. of County Behavioral Health Authorities

9

A Problem in Portsmouth

Photo: Cleveland Plain Dealer

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Opiates in Scioto County

Source: OH Assoc. of County Behavioral Health Authorities

1/10 babies born addicted to drugs in 2010

Admissions for painkiller addiction 5 times national average

Highest rate of Hep C infection in OH in 2010

117 deaths between 2000 and 2008◦ 9/10 caused by prescription drugs◦ 2/3 of dead did not have prescriptions◦ 298 percent increase in OD deaths◦ Saw first decrease in 2010, continue in 2011

11

Scioto County

In June 2003, DEA started receiving complaints from pharmacists and law enforcement from within the State of Ohio, Kentucky and West Virginia regarding Dr. VOLKMAN prescribing multiple prescriptions for Schedules II and III controlled substances

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The Cause

II. The Story of Paul Volkman

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In October 2003, a DEA undercover agent attempts to seek a consultation with VOLKMAN.

For that day, the undercover was denied an appointment at the clinic. No reason given as to why the clinic would not see the undercover.

Possible other reasons for failed attempt:

1) The undercover did not have medical records2) HUFFMAN’s fear of unknowns as being Law Enforcement Operations

14

Investigation

In November 2003, the Drug Control Unit of Kentucky informs DEA that they are unaware of any pharmacies that will fill a prescription written by Dr. VOLKMAN.

“Corresponding Responsibility”21 C.F.R. § 1306.04(a)

DEA regulations provide that pharmacists have a corresponding responsibility to ensure that a prescription that they fill was issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.

15

Investigation

November 2003, DEA receives a complaint from a patient of Dr. VOLKMAN.

The patient complains that VOLKMAN did not give her an examination and that she had to have all her prescriptions filled at the clinic.

When asked if she (patient) could bring a friend she is warned by HUFFMAN not to bring friends around the clinic because it is a dangerous place.

16

Investigation

July 2004, Kentucky State Police (KSP) passes information in regards to RX-EXPRESS Pharmacy located in Russell, Kentucky. A KASPER reports indicates for the period of January 2004 through March 2005 indicates that RX-EXPRESS is filling approximately 85 to 95 percent of VOLKMAN’s prescriptions.

17

Investigation

December 2004, a patient contacted DEA with information that he/she was a patient of VOLKMAN and that after the initial consultation he/she was prescribed

Lorcet, Oxycodone 30mg

XanaxSoma

Investigator’s Note: Lorcet, Xanax & Soma is a noxious combination of drugs that addicts need. Soma which is not a controlled substance metabolizes into meprobamate, a Schedule IV drug with a potential for abuse.

18

Investigation

TRI-STATE HEALTH CARE CLINIC is a CASH ONLY business.

All payments are due up-front (prior to services rendered).

Pharmacy climate required (refusing to fill scripts) TRI-STATE begins dispensing.

Witnesses have seen lines with 50 to 100 people waiting to be seen at the clinic.

19

Investigation

VOLKMAN prescribes and dispenses inordinately large quantity of controlled substances.

No physical examination or very cursory examination was given.

Prescriptions are written inconsistent with legitimate medical treatment.

20

Investigation

Data Trends (of patient surveys)

18% of VOLKMAN/HUFFMAN customershave drug charges pending.

43% of VOLKMAN/HUFFMAN customershave controlled substances convictions

21

Investigation

Starting in February 2005 and continued to April 2005, a DEA Confidential Source participated in three visits to VOLKMAN.

Common factors:

Pay First “CASH ONLY” Blood pressure takenAsk level of painSee Dr. VOLKMANNo medical exam givenVOLKMAN sits with back to CS when writing prescriptionPrescriptions are filled at clinic or RX

22

Investigation

23

Investigation

McKesson: Hydrocodone 10/325

7,000 D/U’s for a one week period.

Moore Medical:Hydrocodone10/325

41,000 D/U’s for a 26 day period.

August 2003 DEA obtained distribution reports from McKesson Medical and Moore Medical both DEA Registrants, as Distributors of Controlled Substances.

457,100

351,000

291,575

262,200

241,100235,300

203,400189,600

168,800164,100

0

50,000100,000150,000

200,000250,000

300,000350,000

400,000450,000

500,000

DO

SAGE

UN

ITS

#1 Practitioner Purchaser of Oxycodone in Nation in 2004

Source: ARCOS Data

457,100

4,160 3,228 3,228 2,940 1,600 680 600 500 4000

50,000100,000150,000

200,000250,000

300,000350,000

400,000450,000

500,000

DO

SAGE

UN

ITS

#1 Practitioner Purchaser of Oxycodone in Ohio in 2004

Source: ARCOS Data

457,100 228,850 23,808 4,7010

100,000

200,000

300,000

400,000

500,000

Paul Volkman, MD ZIP Code 456 Average OH Average U.S. Average

DO

SAGE

UN

ITS

Purchased 97 times the national average for practitioner purchases of oxycodone

Source: ARCOS Data

4%

96%

Paul Volkman, MD457,100 Dosage Units

Remaining 19 Practitioners19,061 Dosage Units

Purchased 96% of oxycodone bought by practitioner purchasers in Ohio

Source: ARCOS Data

457,100

142,600

102,50097,100

64,80058,600

52,90051,400

35,40027,800

24,600

050,000

100,000150,000

200,000250,000

300,000350,000400,000

450,000500,000

DO

SAGE

UN

ITS

#1 Purchaser of Oxycodone compared to pharmacies in Portsmouth

Source: ARCOS Data

457,100 74,259 60,395 37,4440

100,000

200,000

300,000

400,000

500,000

Paul Volkman, MD ZIP Code 456 Average OH Average U.S. Average

DO

SAGE

UN

ITS

Purchased 12 times more oxycodone the average pharmacy in nation

Source: ARCOS Data

Oxycodone◦ #1 in Ohio among physicians in 7/03-9/05◦ #2 nationwide among physicians in 7/03-12/03◦ #1 nationwide among physicians 1/04-9/05◦ #1 in Portsmouth among pharmacies 7/03-12/04

Hydrocodone◦ #1 in Ohio among physicians in 7/03-9/05◦ #1 in Portsmouth among pharmacies 7/03-12/04

Oxycodone & Hydrocodone◦ #1 nationwide among physicians 7/03-12/03◦ #2 nationwide among physicians 1/04-12/04

Volkman by the Numbers

30Source: ARCOS Data

Volkman’s Four “Clinics” TriState: 4/03 – 9/05◦ Gay St. (4/03 – 10/03)◦ Findlay St. (10/03 – 1/06)

Center Street: 9/05 – 10/05

Chillicothe: 10/05 – 2/06

Denise Huffman Alice Huffman 32

Volkman’s Co-Conspirators

“Individuals who are not medical professionals with a license such as clinic owner or managers and pharmacy owners who are not pharmacists may be charged with unlawful distribution of controlled substances or conspiracy to distribute controlled substances “outside the scope of professional practice.”

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Investigation

Cash-Only Business

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HUFFMAN has told patients that if they don’t like the fee increases, that for $500.00 she could get them cocaine, grass, anything.

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Investigation

Law Enforcement Waiver

“I am not appearing to seek care from Paul H. Volkman,

M.D., PhD as part of an ongoing

investigation…”

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United States v. Moore423 U.S. 122(1975)

“[R]egistered physicians can be prosecuted under [21 U.S.C.]§ 841 when their activities fall outside the usual course of professional practice.” at 124

37

Investigation

“Dear Dr. Hurwitz” (10/03)

“It is a pleasure to make contact with another professional of like mind and approach . . .

It is reassuring to find that the approach that I have adopted appears similar to yours. Of course, you have been thrown in jail for your efforts, so I’m not sure why I am reassured.”

FACTORS

No Doctor – Patient Relationship

Lack of [Complete] Medical Records

No cursory physical exam & medical history

Prescriptions for people not present

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Investigation

“Total Isolation”

“I am new to the pain business, about 7 months, and have had to develop dosing schedules in total isolation (amidst scorn, vilification, and disapproval).”

“We are striving to be totally self-contained by having our own pharmacy.”

“A brilliant, tough matriarch”

“Our clinic was started . . . by Denise Huffman, a brilliant, tough matriarch…

“Denise and I realized that the only way to continue was to start our own pharmacy and dispense all the scripts that I wrote…”

“Guns in their purses”

“[Denise] and her daughter and nieces all have guns in their purses.

“As far as security, we have 3 to 4 large armed men in the clinic, and video and infaredcameras all about the building.”

Volkman’s Prescriptions Wrote for “the best and the most” Euphoria-inducing drugs: ◦ Oxycodone◦ Hydrocodone◦ Benzodiazepines (Xanax or Valium)◦ Soma

Large numbers of pills High doses of pills The more you came, the more you got

Narcotic prescribed 98% of time

98%

2%

Narcotic Prescribed

44

Two Immediate Release Narcotics Prescribed 85% of time in Same Visit

85%

15%

00

Two Prescribed

Two Not Prescribed

45

Oxycodone Prescribed 89% of time

89%

11%0 0

Oxycodone Prescribed

Oxycodone Not Prescribed

46

30 mg prescribed 74% of time

74%

26%

0 0

Strongest Tablet (30 mg)

Other Tablet (5 mg, 15 mg)

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Hydrocodone prescribed 81% of time

81%

19%

0 0

Hydrocodone Prescribed

Hydrocodone Not Prescribed

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Strongest hydrocodone 100% of time

100%

000

Strongest Tablet

49

Benzodiazepine prescribed 85% of time

85%

15%

00

Benzodiazepine Prescribed

Benzodiazepine Not Prescribed

50

Strongest Valium – 99.6%

99.6%

0.4%00

Strongest Tablet (10 mg)

Other

51

Strongest Xanax – 97.6%

97.6%

2.4% 00

Strongest Tablet (2 mg)

Other

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Concerned about prescriptions◦ Types of pills◦ Strength of pills◦ Number of pills◦ Combination of pills

Concerned about patients◦ Travelled long distances◦ No visible signs of pains◦ Young◦ Arrived in groups◦ Not concerned about cost

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Pharmacist Concerns

Death by

Multi Drug Intoxication

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Effects

Operation of Dispensary

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Result: 1 million missing pills

“I am also identifying and witnessing all of the dispensed medications. I initial the back of each prescription and verify each filled medication before it is dispensed.”

Inside Tri-State – 1/0461 MinutesWaiting Room6 Minutes “Assessment” by Staff36 MinutesWait for Doctor9 Minutes“Examination” by Doctor

No Medical Examination

•No one • took pulse• listened to breathing• took blood pressure• weighed her

•Received Oxy 30, Percocet, Norco, Soma, Xanax

Basic Exchange: Cash for Scripts

Prescriptions - Before & After

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Mg/Day

Prescription Date 60

Trend: More Drugs over Time

0

50

100

150

200

250

300

Mg/Day

Prescription Date

Benzodiazepines

Oxycodone

Hydrocodone

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Forged Medical Records

“b) The patient has currently improved in these areas compared to the time when she has been on drug holidays from controlled substances”

Problem: Risks of Opiates Benefits: Pain Relief Risks◦ Addiction◦Diversion◦ Patient Safety Frequency (“stacking”) Combination (“synergistic”) Interaction with health conditions

Toxicological Chaos

3-5 pills every 2 hours30 pills per day

Sham Controls Prior Records Pill Counts Urine Screens

“Levels” and “Clinical Trials” “Levels” = numbers

showing whether taking medicine as prescribed

“Clinical trials” = take pills and sit in waiting room

Observations of Tri-State – 6/05

No equipment to view X-rays No equipment to view MRI’s No way to wash hands (no soap) No thermometer Pills in desk drawers Urine specimens on floor Medical records in kitchen or stove

Center Street: 9/05-10/05 Run out of his apartment Rough part of town Parking quickly became an

issue New day for individuals

kicked out of Tristate One witness: like a grocery

store – people come in and out, very busy

“Drug Sheet”

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800% increase, no exam

Chillicothe: 10/05 – 2/06 6-10 cars waiting

at 6:00 am

Brought in $9,500 in one day

Video monitoring, but no examination table

No ability to read X-ray or MRI film

Operations at Chillicothe Volkman◦ Didn’t want to see x-rays◦ Didn’t listen to heart or lungs◦ Didn’t even have a stethoscope ◦ Complained patients made more than he did◦ Said patients would “limp in an dance out”

Wheelchair by day / dancing by night Workers there past 1:30 am “Strong but irregular heartbeat” – a

concern, but not at that office

“Informed Consent”

“. . . Pt may experience respiratory depression due to combination of Xanax, Soma, Oxycodone, Hydrocodone. Pt. accepts risk of resp. depression + premature demise because of improved qualify of life with this pain medication.”

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A first-time patient - 10/21/05 Drug Amount # Pills / Day # Pills /

Month

Oxycodone 30 mg 8 240

Lortab 10 / 325 mg 8 240

Xanax 2 mg 3 90

Soma 350 mg 3 90

Total 22 660

9 under age of 40

All prescribed combination of opiate and sedatives

11 received increase on last visit

8 died within 3 days of visit

At least 12 patient deaths

75

Conspiracy – 1 count

Illegal Distribution – 13 counts

Deaths – 11 instances

Firearms – 2 counts

Drug House – 4 counts

76

IV. Charges

United States must prove physician acted outside course of professional practice and not for legitimate medical purpose

Instructions on good faith:

77

Illegal Distribution

“Good faith” in this context means good intentions and an honest exercise of professional judgment as to a patient’s needs It means that the Defendant acted in accordance with what he reasonably believed to be proper medical practice.

United States must prove that “death resulted from use of the substance distributed”

Instructions on death charges:

“Death resulted”

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… the Government need not prove that the death was foreseeable to the Defendant. But the Government must prove beyond a reasonable doubt that the death would not have occurred had the mixture and substance . . . Dispensed by the Defendant not been ingested by the individual.”

110 potential jurors

10 weeks: 3/1/11-5/9/11◦ 8 weeks of trial◦ 5 ½ days of deliberation (over 2 weeks)

80 witnesses ◦ Traveled from 8 states◦ 70 called by US ◦ 10 called by Defendant

300+ exhibits in 28 binders

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V. Trial

17 patients

4 family members

2 co-conspirators

9 employees

2 landlords

1 yoga instructor

Fact Witnesses

80

5 experts

7 pharmacists

8 coroners

8 pathologists

11 toxicologists

81

Medical Witnesses

Types of Drugs

Effect of Drugs

Dosing & Metabolism Amount Frequency Number of Drugs

Patient-Specific Red Flags Physical Psychological

Death Charges – Science

82

Key Evidence Medical Records Prescription Records Data re: other doctors Autopsy Report Toxicology Report Coroner re: Scene Death Certificate Family Members

83

Individual Requires proof of regular compliance Dynamic – can be gained, can be lost Limited – fatal dose does exist

The Defense of Tolerance

84

The reality of the “fatal dose” Name Amount of Increase Days After Visit

B.B. 800% 2M.C. 25% + 33% 2D.C. 50% 5J.E. 33% 1A.G. 50% + New Drug 2S.H. 300% 1S.J. 2 New Drugs 4C.J. 100% 5D.P. 25% 1E.R. 4 New Drugs 2K.R. 100% 1

85

Conviction on 18/20 counts

◦ Conspiracy – Guilty on 1 count

◦ Drug houses – Guilty on all 4 counts

◦ Firearm – Guilty on 1 of 2 counts

◦ Illegal distribution – Guilty on 12 of 13 counts

Deaths – guilty on 4 of 11 charges

86

Verdict – 5/9/11

Effect of Proving Death

Drug Amount

Enhancements◦ Vulnerable Victims

◦ Abuse of Position of Trust

Comparative Sentences

Consecutive versus Concurrent

87

Sentencing - 2/14/12

February 23, 2012Email:From Ohio Department of HealthSubject: Scioto County is Sharing Some Good News

I wanted to let you know that we have had a reductionin overdose deaths…. there has been a 17% decreasein accidental OD’s and a 42% decrease in drug related deaths.

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It COUNTS!

CONCLUSION

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